Programación errónea de una bomba de TCI. Caso SENSAR del trimestre / Incorrect programming of a target controlled infusion pump. Case SENSAR of the trimester

Reportamos el caso de un paciente que fue intervenido de un recambio valvular aórtico. Durante el mantenimiento de la anestesia general se administró una perfusión de remifentanilo mediante un sistema de infusión tipo «target controlled infusion» (TCI, «infusión controlada por objetivo»). La bomba de infusión previamente preparada para la intervención presentó un error de funcionamiento al iniciarse su uso, por lo que fue sustituida velozmente por una segunda bomba. Tras unos minutos de cirugía el paciente presentó hipotensión arterial refractaria al tratamiento. Además, se observó que la jeringa de remifentanilo se acabó antes de lo esperable. Se revisó la bomba de infusión, observándose que estaba programada por error para propofol en vez de para remifentanilo, por lo que el paciente había recibido hasta ese momento una dosis de remifentanilo muy elevada, que probablemente fue la causa de las alteraciones hemodinámicas. El incidente fue un error en el uso del equipamiento, favorecido por la prisa, la falta de comprobación del material antes de su uso y el diseño habitualmente complejo y poco claro de las pantallas de los dispositivos de infusión tipo TCI. Tras el análisis, se revisaron todas las bombas de TCI, eliminándose programaciones de fármacos no utilizadas rutinariamente. Asimismo, se destinaron 2 bombas de TCI para uso exclusivo en el quirófano de cirugía cardiaca, una con programación única para remifentanilo y otra para propofol, se rotularon externamente de forma inequívoca y se ubicaron en una localización fija en dicho quirófano (AU)

We report the case of a patient who underwent surgical aortic valve replacement. During general anaesthesia maintenance, the patient received a remifentanyl infusion via a target controlled infusion (TCI) system. The infusion pump that was prepared to deliver the infusion showed malfunction at the beginning of the surgery, so it was quickly replaced with a second pump. After a few minutes into the surgery, the patient presented with hypotension refractory to treatment. The remifentanyl syringe also emptied faster than expected. On reviewing the TCI pump, it was found that it was erroneously programmed for propofol instead of remifentanyl, thus the patient had received a very high dose of remifentanyl that was probably the cause of the haemodynamic disturbances. The incident was an error in equipment use, facilitated by hurry, lack of checking of the equipment prior to its use, and the complex and unclear design of the devices’ screens. After analysis of this incident, all TCI pumps were reviewed, and all the programs for infrequently used drugs were deleted. Furthermore, 2 pumps were selected for exclusive use in the cardiac surgery theatre, one with propofol-only programming, and the other with remifentanyl-only programming, both clearly marked and situated in fixed places in that theatre (AU)

A cost-effectiveness analysis of a proactive management strategy for the Sprint Fidelis recall: a probabilistic decision analysis model.

BACKGROUND: The management of the recall is complicated by the competing risks of lead failure and complications that can occur with lead revision. Many of these patients are currently undergoing an elective generator change--an ideal time to consider lead revision. OBJECTIVE: To determine the cost-effectiveness of a proactive management strategy for the Sprint Fidelis recall. METHODS: We obtained detailed clinical outcomes and costing data from a retrospective analysis of 341 patients who received the Sprint Fidelis lead in British Columbia, where patients younger than 60 years were offered lead extraction when undergoing generator replacement. These population-based data were used to construct and populate a probabilistic Markov model in which a proactive management strategy was compared to a conservative strategy to determine the incremental cost per lead failure avoided. RESULTS: In our population, elective lead revisions were half the cost of emergent revisions and had a lower complication rate. In the model, the incremental cost-effectiveness ratio of proactive lead revision versus a recommended monitoring strategy was $12,779 per lead failure avoided. The proactive strategy resulted in 21 fewer failures per 100 patients treated and reduced the chance of an additional complication from an unexpected surgery. CONCLUSIONS: Cost-effectiveness analysis suggests that prospective lead revision should be considered when patients with a Sprint Fidelis lead present for pulse generator change. Elective revision of the lead is justified even when 25% of the population is operated on per year, and in some scenarios, it is both less costly and provides a better outcome.

Cost efficiency and reimbursement of remote monitoring: a US perspective.

Demographic and technological changes are driving increased utilization of cardiac implantable electronic devices (CIEDs) remote monitoring. In the USA, fee-for-service model of healthcare delivery, services rendered are valued based upon time, intensity, and technical or practice expense costs. As a consequence of this perspective, and to contain spending, Medicare has grouped physician services into families. Spending within each family of services must, by law, remain budget neutral. Cardiac implantable electronic devices monitoring services, remote and in-person, are grouped into one family. As the volume of services within this family increases, the individual encounters are destined to be discounted into ever decreasing portions. However, if the value of remote monitoring is demonstrated to extend beyond the previous boundaries of in-person interrogations, a rational request can be made to reconsider the relative value of remote monitoring. Outcome data supporting the value-added benefits of remote monitoring are rapidly accumulating, including (i) patient convenience, with reduced use of office services, (ii) equal safety compared with in-person evaluation, (iii) shorter detection time to actionable events (arrhythmias, cardiovascular disease progression, and device malfunction), (iv) reduced length of stay for hospitalizations, (v) reduced inappropriate shocks, (vi) increased battery longevity, and (vii) a relative reduction in the risk of death. Fully automatic wireless technology, only recently widely implemented, will add considerable clinical efficiencies and further increase the value of remote monitoring. The U.S. challenge will be to appropriately define the relative value of CIEDs remote monitoring now that outcome data have demonstrated its value extends beyond in-person interrogation.

Remote monitoring costs, benefits, and reimbursement: a European perspective.

AIMS: To provide a European perspective on reimbursement issues surrounding remote monitoring of cardiac implantable electronic devices in view of the anticipated costs and benefits. METHODS AND RESULTS: Review of recent literature addressing clinical, economic, sociocultural, and technological factors associated with remote monitoring. When healthcare transformation is urgently needed, remote monitoring offers opportunities to innovate and cope with escalating costs and constrained resources, while improving patient safety, quality, and access to care as reflected in clinical studies. The introduction of remote monitoring into daily practice requires analysis of reimbursement policies to address funding scope, payment method, payer, price and allocation, and alignment with health system objectives and goals to ensure financial and operational sustainability of resources, infrastructure, and processes. Remote monitoring policies should gradually transition from activity-based, added-value services in a care-and-cure setting, to performance and outcome-oriented highlighting prevention, surveillance, and empowerment. By encouraging and rewarding innovation and interoperability, proprietary remote monitoring technologies can open up using standards and connect to support a growing evidence base that guides clinical decision support and planning of future policies. CONCLUSION: Careful planning, sharing of experiences, and gradual adoption of reimbursement models that focus on outcome, performance, and cost-effectiveness are key aspects of containing escalating costs and improving quality and access to healthcare. Despite differences in health systems and payment methods in Europe, policy-makers, professional societies, payers, providers, and the industry need to join forces to transform healthcare and make innovation happen.

Remote monitoring of cardiac implantable devices in the Asia-Pacific.

Remote monitoring of pacemakers and implantable cardioverter defibrillators (ICDs) has emerged as a tool to replace regular follow-up of such devices, and to detect hardware failure, arrhythmias, and heart failure decompensation. The Asia-Pacific region is a geographically diverse area, with widely different cardiac device implant rates and expertise. However, common to all countries, distance and logistic for patients to reach an expert monitoring centre for routine follow up are significant, and in some countries, this will likely be replaced by remote monitoring. Unscheduled visits such as for the treatment of atrial fibrillation and ICD shocks will be expedited. There has been an increase in both pacemaker and ICD implant rates in Asia-Pacific, due to an ageing population and improvement in economic condition. Among the countries, Australia and Japan are the major users of remote monitoring. According to the statistics of the suppliers, in Australia, up to 15% of pacemakers, 40% ICD, and 30% cardiac resynchronization therapy (CRT)/cardiac resynchronization therapy defibrillator (CTRD) are remotely monitored. The corresponding numbers for Japan are 5, 50, and 50% respectively. The monitoring personnel include nurses, technicians, and doctors, either from local centre or from device companies. Cost, lack of reimbursement, and logistic support are major issues in widespread application of remote monitoring technology. In conclusion, remote monitoring is increasing in Asia-Pacific region despite the increase in cost. Implantable cardioverter defibrillators and CRT/CRTDs are more likely than pacemakers to be enabled with remote monitoring.

[The costs for different voice prostheses depending on the lifetime]. / Die Kosten für verschiedene Stimmprothesenmodelle in Abhängigkeit der durchschnittlichen Liegezeit.

Voice prostheses are available in different types of architecture und from different producers. Especially the ones with antifungal properties are characterized by a high pricing. The aim of this paper is to check, whether these prices are reflected by the prosthesis life time.A Benchmarking with usage of mean lifetime and prosthesis costs. Comparing Provox 1, Provox 2, Provox Vega, Provox ActiValve, ESKA-Herrmann, Blom Singer Classic, Phonax, Blom Singer Advantage.The voice prosthesis Provox 1 offers the best price-lifetime-ratio (1.0). It's 6.7-times higher than the one of the Provox ActiValve (0.15). In addition, the classic prostheses Provox 2 (0.53), Blom Singer Classic (0.54) and ESKA-Herrmann (0.72) offer a good ratio compared to Provox 1, too.The mean lifetime of the voice prostheses do not reflect the pricing. The Provox 1 offers the best ratio and should be used as a reference in pricing the prostheses.

Economic impact of remote monitoring on ordinary follow-up of implantable cardioverter defibrillators as compared with conventional in-hospital visits. A single-center prospective and randomized study.

INTRODUCTION: Few data are available on actual follow-up costs of remote monitoring (RM) of implantable defibrillators (ICD). Our study aimed at assessing current direct costs of 1-year ICD follow-up based on RM compared with conventional quarterly in-hospital follow-ups. METHODS AND RESULTS: Patients (N = 233) with indications for ICD were consecutively recruited and randomized at implant to be followed up for 1 year with standard quarterly in-hospital visits or by RM with one in-hospital visit at 12 months, unless additional in-hospital visits were required due to specific patient conditions or RM alarms. Costs were calculated distinguishing between provider and patient costs, excluding RM device and service cost. The frequency of scheduled in-hospital visits was lower in the RM group than in the control arm. Follow-up required 47 min per patient/year in the RM arm versus 86 min in the control arm (p = 0.03) for involved physicians, generating cost estimates for the provider of USD 45 and USD 83 per patient/year, respectively. Costs for nurses were comparable. Overall, the costs associated with RM and standard follow-up were USD 103 ± 27 and 154 ± 21 per patient/year, respectively (p = 0.01). RM was cost-saving for the patients: USD 97 ± 121 per patient/year in the RM group versus 287 ± 160 per patient/year (p = 0.0001). CONCLUSION: The time spent by the hospital staff was significantly reduced in the RM group. If the costs for the device and service are not charged to patients or the provider, patients could save about USD 190 per patient/year while the hospital could save USD 51 per patient/year.

Canadian Registry of ICD Implant Testing procedures (CREDIT): current practice, risks, and costs of intraoperative defibrillation testing.

BACKGROUND: There is uncertainty about the proper role of defibrillation testing (DT) at the time of implantable cardioverter defibrillator (ICD) insertion. METHODS: A prospective registry was conducted at 13 sites in Canada between January 2006 and October 2007. OBJECTIVES: To document the details of DT, the reasons for not conducting DT, and the costs and complications associated with DT. RESULTS: DT was conducted at implantation in 230 of 361 patients (64%). DT was more likely to be conducted for new implants compared with impulse generator replacements (71% vs 32%, P = 0.0001), but was similar for primary and secondary prevention indications (64% vs 63%, P = NS). Among patients not having DT, the reason(s) given were: considered unnecessary (44%); considered unsafe, mainly due to persistent atrial fibrillation (37%); lack of an anesthetist (20%); and, patient or physician preference (6%). When performed, DT consisted of a single successful shock > or = 10J below maximum device output in 65% of cases. A 10J safety-margin was met by 97% of patients, requiring system modification in 2.3%. Major perioperative complications occurred in 4.4% of patients having DT versus 6.6% of patients not having DT (P = NS). ICD insertion was $844 more expensive for patients having DT (P = 0.16), largely due to increased costs ($28,017 vs $24,545) among patients having impulse generator replacement (P = 0.02). CONCLUSIONS: DT was not performed in a third of ICD implants, usually due to a perceived lack of need or relative contraindication.

[Telemonitoring of implantable devices. Practical aspects and ongoing studies]. / Telemonitoring implantierbarer Aggregate. Praktische Aspekte und laufende Studien.

Telemedicine is used in various areas of cardiology, e.g., for the detection of cardiac arrhythmias and monitoring coronary artery disease and heart failure. Telemedicine is playing an increasing role is the monitoring of implantable devices (pacemakers, defibrillators, and event recorders). Most manufacturers of these devices have, in the meantime, telemedical concepts. The current guidelines of cardiac societies advocate the implantation of telemedicine-controlled devices. In the practical implementation of telemedicine devices, recruitment and involvement of patients, setting up of telemedicine consultation, legal aspects, and financing questions are of special relevance.

Time and motion study of radiotherapy delivery: Economic burden of increased quality assurance and IMRT.

Time measurements were performed on daily treatment delivery with the aim to quantify the impact of quality assurance (QA) using an electronic portal imaging device (EPID) on RT delivery time and to validate the time burden of intensity modulated radiation therapy (IMRT) as an example of advanced technology. Both increased QA and the delivery of IMRT were found to be significant parameters determining daily treatment time (TT), which in turn translates in increased treatment costs.

Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems.

AIMS: Comparative studies on the longevity of implantable cardioverter-defibrillators (ICDs) among different manufacturers have never been reported. Longevity of ICD devices implanted from 1 January 2000 to 31 December 2002 was prospectively investigated according to their type and manufacturer. METHODS AND RESULTS: Longevity of single-chamber (SC), double-chamber (DC), and biventricular (CRT-D) ICDs from Medtronic (MDT), Guidant (GDT), and St Jude Medical (SJM) was measured in all the patients who required device replacement. The observation follow-up ended on 31 December 2007; patients who died prematurely or were transplanted before battery exhaustion were excluded from the analysis. Factors associated with longevity (number of delivered shocks, pacing activity) were researched. One hundred and fifty-three patients received an ICD in the abovementioned period. Six underwent heart transplantation, and 23 died before device replacement; 80 had an SC device, 59 had DC device, and 14 had CRT-D device. Longevity of MDT was superior to GDT and SJM, replacement rates being, respectively, 42%, 95.3%, and 97.2%. Only MDT manufacturers and SC type were associated with greater ICD longevity. Longevity had an impact on the cost/month of treatment of replaced ICDs. CONCLUSION: Battery longevity is significantly different among manufacturers. ICD cost is strictly dependent on device longevity, whereas device up-front cost is of limited clinical meaning. Appropriate assessment of cost-effectiveness should be based on ICD longevity in the real-life scenario.